Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04499612 |
Other study ID # |
05/290120 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2020 |
Est. completion date |
November 1, 2023 |
Study information
Verified date |
October 2022 |
Source |
Ryazan State Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The hemostasis system is one of the many biological systems of the human body, designed to
preserve the liquid state of blood and prevent its loss during vascular injuries. The ideal
balance between its coagulant and anticoagulant components never occurs. In various diseases
and pathological conditions, the balance of the hemostasis system may be disturbed. Shifts
towards hypercoagulability lead to the development of hemorrhagic complications, opposite
shifts lead to the development of thrombotic complications.
Patients with cardiac implantable electronic devices (CIED) are not rare and unique, today
doctors meet with them every day. Its more than 1.5 million CIED's implanted every year.
Before surgery these patients are standard cardiology department patients with chronic heart
failure (CHF), which develops due to the presence of arrhythmias, coronary heart disease,
hypertension, congenital heart disease, myocardial infarction, myocarditis or other diseases
and conditions. CHF is the most common, severe and unfavorable prognostic complication of
these diseases. With CHF, the balance of the hemostasis system shifts towards
hypercoagulation. Patients with CHF have an increased risk of arterial and venous thrombosis,
pulmonary embolism, myocardial infarction, stroke, numerous brady- and tachyarrhythmias and
other complications.
After CIED implantation, bradyarrhythmia is eliminated, as one of the parts in the
pathogenesis of CHF. Patients, especially those with severe symptoms, improve their condition
in the early postoperative period. In the long-term period, pacing, on the contrary, may
contribute to the progression of CHF. The wrong choice of pacing mode or the place of
electrode implantation can lead to desynchronization of the heart chambers, myocardial
remodeling and left ventricular dysfunction.
Uncertainty is also observed in relation to the hemostasis system after CIED implantation. On
the one hand, correction of bradyarrhythmia and CHF should provide patients with a shift
towards hypocoagulability by normalizing the heart rate. On the other hand, trauma to the
vessel wall during surgery, further placement of the CIED leads in the vessels, and
perioperative stress can lead to even greater shifts towards hypercoagulation.
Description:
250 patients of similar age, gender, and ethnicity will be divided into five groups: Group
A1-3: 150 patients with indications for cardiac implantable electronic device (CIED)
implantation; Group B: 50 patients with an CIED implanted 8-10 years ago; Group C: 50
patients with diseases similar to group A, but without indications for CIED implantation;
Patients will be followed up for 2 years. Patients of group A1-3 will be taken peripheral
venous blood to assess the studied parameters of hemostasis (platelet count, plateletcrit,
mean platelet volume, platelet distribution width, von Willebrand factor, P-selectin,
coagulation factor I (FI), coagulation factor II (FII), coagulation factor V (FV),
coagulation factor VII (FVII), coagulation factor X (FX), coagulation factor VIII (FVIII),
coagulation factor IX (FIX), coagulation factor XI (FXI), coagulation factor XII (FXII),
plasminogen, soluble fibrin, plasminogen activator inhibitor-1 (PAI-1), D-dimer, antithrombin
III, protein C) and duplex ultrasound of the vessels of the upper and lower extremities
before the operation, after 7 days, 1 and 12 months after the operation. Similar procedures
will be performed for patients of groups B and C only when included in the study.
Echocardiography will be performed on all patients at enrollment, after 12 and 24 months of
follow-up.